Sarepta To Request FDA For Traditional Approvals For Duchenne Drugs - Sarepta Therapeutics (NASDAQ:SRPT)
Published on March 19, 2026.
Sarepta Therapeutics (NASDAQ:SRPT) plans to submit supplemental new drug applications to the U.S. Food and Drug Administration (FDA) by the end of April. The company is seeking to convert accelerated approvals of AMONDYS 45 (casimersen) and VYONDYS 53 (golodirsen) to traditional approvals. The FDA has confirmed that Sarepta can submit ESSENCE data and real-world evidence as part of these applications. The stock is currently trading 2.3% below its 20-day simple moving average (SMA) and 15.3%. Shares have decreased 78.54% over the past 12 months and are positioned closer to their 52-week lows than highs.
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